Senior Executive – Regulatory Affairs (BIS & CDSCO)

Job Summary

We are looking for an experienced Senior Executive – Regulatory Affairs to independently handle BIS and CDSCO registrations, certifications, licensing, regulatory documentation, and compliance activities. The candidate will be responsible for managing regulatory applications from documentation and submission through follow-up, queries, approvals, and renewals.

Key Responsibilities

- Handle end-to-end BIS/ISI certification processes, including application preparation, product testing, laboratory coordination, inspection, documentation, and certification.
- Manage CDSCO registrations and licensing through the SUGAM Portal, including preparation, submission, follow-up, and response to regulatory queries.
- Handle product classification and assess applicable BIS/CDSCO regulatory requirements.
- Prepare, review, and maintain DMF, PMF, SOPs, technical files, declarations, and other regulatory documents.
- Review technical and regulatory documents for accuracy, completeness, and compliance before submission.
- Coordinate with BIS/CDSCO authorities, government departments, laboratories, consultants, and clients for applications, inspections, queries, and approvals.
- Monitor application status and ensure timely follow-up for approvals, renewals, amendments, and other regulatory requirements.
- Handle regulatory queries, objections, and deficiencies and coordinate with the concerned stakeholders for timely resolution.




- Maintain proper records and trackers for all ongoing and completed regulatory cases.
- Keep updated with changes in BIS standards, CDSCO regulations, notifications, guidelines, and applicable regulatory requirements.
- Provide regulatory guidance and timely updates to clients regarding their applications and compliance requirements.
- Coordinate with internal teams to ensure timely completion of documentation and client requirements.
- Manage multiple regulatory projects simultaneously while ensuring accuracy and adherence to timelines.

Required Skills & Qualifications
- 2–6 years of relevant experience in Regulatory Affairs, preferably in BIS/ISI and CDSCO/Medical Devices.
- Hands-on experience with BIS Manakonline and CDSCO SUGAM Portal.
- Strong knowledge of BIS certification, product testing, laboratory coordination, and CDSCO registration/licensing processes.
- Good understanding of DMF, PMF, technical documentation, SOPs, and regulatory submissions.
- Strong documentation, communication, coordination, and follow-up skills.
- Ability to independently manage multiple regulatory applications and deadlines.
- Valuable client-handling and problem-solving skills.
- Knowledge of applicable Indian regulatory and compliance requirements.

Preferred Qualification B.Pharm / M.Pharm / Biomedical Engineering / Biotechnology / Life Sciences or a relevant regulatory/technical qualification.

Pay: ₹25,000.00 - ₹40,000.00 per month

Work Location: In person

📌 Senior Executive – Regulatory Affairs (BIS & CDSCO) (North Sikkim)
🏢 Legal Raasta Technologies
📍 North Sikkim